Ablation system and method of use

ABSTRACT

A system and method for creating lesions and assessing their completeness or transmurality. Assessment of transmurality of a lesion is accomplished by monitoring the impedance of the tissue to be ablated. Rather than attempting to detect a desired drop or a desired increase impedance, completeness of a lesion is detected in response to the measured impedance remaining at a stable level for a desired period of time, referred to as an impedance plateau. The mechanism for determining transmurality of lesions adjacent individual electrodes or pairs may be used to deactivate individual electrodes or electrode pairs, when the lesions in tissue adjacent these individual electrodes or electrode pairs are complete, to create an essentially uniform lesion along the line of electrodes or electrode pairs, regardless of differences in tissue thickness adjacent the individual electrodes or electrode pairs.

RELATED US APPLICATION DATA

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/132,379 filed Apr. 24, 2002 now U.S. Pat. No. 6,648,883 andalso claiming priority to Provisional U.S. Patent Application No.60/287,202, filed Apr. 26, 2001 by Francischelli et al., incorporatedherein by reference in its entirety.

BACKGROUND OF THE INVENTION

The present invention relates to tissue ablation devices generally andrelates more particularly to devices adapted to ablate lines of tissue,for example for use in conjunction with an electrosurgical version ofthe Maze procedure.

The Maze procedure is a surgical intervention for patients with chronicatrial fibrillation (AF) that is resistant to other medical treatments.The operation employs incisions in the right and left atria which dividethe atria into electrically isolated portions which in turn results inan orderly passage of the depolarization wave front from the sino-atrialnode (SA Node) to the atrial-ventricular node (AV Node) while preventingreentrant wave front propagation. Although successful in treating AF,the surgical Maze procedure is quite complex and is currently performedby a limited number of highly skilled cardiac surgeons in conjunctionwith other open-heart procedures. As a result of the complexities of thesurgical procedure, there has been an increased level of interest inprocedures employing electrosurgical devices or other types of ablationdevices, e.g. thermal ablation, micro-wave ablation, cryo-ablation orthe like to ablate tissue along pathways approximating the incisions ofthe Maze procedure. Electrosurgical systems for performing suchprocedures are described in U.S. Pat. No. 5,916,213, issued toHiassaguerre, et al. U.S. Pat. No. 5,957,961, issued to Maguire, et al.and U.S. Pat. No. 5,690,661, all incorporated herein by reference intheir entireties. Cryo-ablation systems for performing such proceduresare described in U.S. Pat. No. 5,733,280 issued to Avitall, alsoincorporated herein by reference in its entirety.

In conjunction with the use of electrosurgical ablation devices, variouscontrol mechanisms have been developed to control delivery of ablationenergy to achieve the desired result of ablation, i.e. killing of cellsat the ablation site while leaving the basic structure of the organ tobe ablated intact. Such control systems include measurement oftemperature and impedance at or adjacent to the ablation site, as aredisclosed in U.S. Pat. No. 5,540,681, issued to Struhl, et al.,incorporated herein by reference in its entirety.

Additionally, there has been substantial work done toward assuring thatthe ablation procedure is complete, i.e. that the ablation extendsthrough the thickness of the tissue to be ablated, before terminatingapplication of ablation energy. This desired result is some timesreferred to as a “transmural” ablation. For example, detection of adesired drop in electrical impedance at the electrode site as anindicator of transmurality is disclosed in U.S. Pat. No. 5,562,721issued to Marchlinski et al, incorporated herein by reference in itsentirety. Alternatively, detection of an impedance rise or an impedancerise following an impedance fall are disclosed in U.S. Pat. No.5,558,671 issued to Yates and U.S. Pat. No. 5,540,684 issued to Hassler,respectively, also incorporated herein by reference in their entireties.

Three basic approaches have been employed to create elongated lesionsusing electrosurgical devices. The first approach is simply to create aseries of short lesions using a contact electrode, moving it along thesurface of the organ wall to be ablated to create a linear lesion. Thiscan be accomplished either by making a series of lesions, moving theelectrode between lesions or by dragging the electrode along the surfaceof the organ to be ablated and continuously applying ablation energy, asdescribed in U.S. Pat. No. 5,897,533 issued to Mulier, et al.,incorporated herein by reference in its entirety. The second basicapproach to creation of elongated lesions is simply to employ anelongated electrode, and to place the elongated electrode along thedesired line of lesion along the tissue. This approach is described inU.S. Pat. No. 5,916,213, cited above and. The third basic approach tocreation of elongated lesions is to provide a series of electrodes andarrange the series of electrodes along the desired line of lesion. Theelectrodes may be activated individually or in sequence, as disclosed inU.S. Pat. No. 5,957,961, also cited above. In the case ofmulti-electrode devices, individual feedback regulation of ablatedenergy applied via the electrodes may also be employed. The presentinvention is believed useful in conjunction with all three approaches

SUMMARY OF THE INVENTION

The present invention is directed toward an improved system for creatinglesions and assessing their completeness or transmurality. Inparticular, the preferred embodiments of the invention are directedtoward an improved system for creating elongated lines of lesion andassessing their completeness or transmurality. In the preferredembodiment as disclosed, the apparatus for producing the lesions is anelectrosurgical device, in particular a saline-irrigated bipolarelectrosurgical forceps. However, the mechanism for assessing lesiontransmurality provided by the present invention is believed useful inother contexts, including unipolar radio-frequency (RF) ablation and RFablation using catheters or hand-held probes. The mechanism forassessing transmurality may also be of value in the context of othertypes of ablation systems, particularly those which ablation occurs inconjunction with an induced rise in tissue temperature such as thoseapplying ablation energy in the form of microwave radiation, light(laser ablation) or heat (thermal ablation).

According to the present invention, assessment of transmurality of alesion is accomplished by monitoring the impedance of the tissue to beablated. The inventors have determined that, particularly in the case ofa saline-irrigated electrosurgical ablation device, tissue impedancefirst falls and then reaches a stable plateau, during which portion thelesion is completed. Thereafter, the impedance rises. Rather thanattempting to detect a desired drop or a desired increase impedance asdescribed in the above cited Yates, Hassler and Marchlinski patents, thepresent invention detects completeness of a lesion in response to themeasured impedance remaining at a stable level for a desired period oftime, hereafter referred to as an impedance plateau. In the context ofRF ablation, measurement of impedance may be done using the ablationelectrodes or may be done using dedicated electrodes adjacent to theablation electrodes. In the context of the other types of ablationdiscussed above, impedance measurement would typically be accomplishedby means of a dedicated set of impedance measurement electrodes.

In the context of RF ablation, the invention is believed most valuablein the conjunction with an ablation device having multiple, individuallyactivatable electrodes or electrode pairs to be arranged along a desiredline of lesion. In this context, the mechanism for determiningtransmurality of lesions adjacent individual electrodes or pairs may beused to deactivate individual electrodes or electrode pairs, when thelesions in tissue adjacent these individual electrodes or electrodepairs are complete. This allows the creation of an essentially uniformlesion along the line of electrodes or electrode pairs, regardless ofdifferences in tissue thickness adjacent the individual electrodes orelectrode pairs. However, the invention is also believed useful inconjunction with assessment of transmurality of lesions produced bydevices having only a single electrode or single electrode pair. Similarconsiderations apply to the use of the present invention in the contextsof other types of ablation as listed above.

In yet another aspect of the invention, RF power delivery can also becontrolled in order to assess lesion transmurality. The ablation willcommence at a first power level and will be increased to a second powerlevel as certain conditions are satisfied. The power level can also beincreased from the second power level to a third power level as certainconditions are satisfied. The increase in power level can continue inthe same stepwise manner, increasing the power level from an N powerlevel to an n+1 power level until a set of conditions are met thatindicates that transmurality has been achieved and/or that the powershould be turned off. Conditions for an increase in power level caninclude one or more of: the detection of a plateau in impedance or theachievement of a maximum permitted time for that power level. Conditionsindicating that transmurality has been achieved can include one of: thelack of change in detected impedance in response to the change in powerlevel or the detection of a rapid rise in impedance. If transmurality isdetected by satisfying one of these conditions, the power is turned offand the ablation is complete. If a condition indicating thattransmurality has been achieved is not detected, such as a drop indetected impedance in response to the change to the higher power level,ablation is continued at the higher power level until the conditions aremet for again increasing the power level or conditions indicatingtransmurality are met. This process may be continued in a stepwisefashion until the conditions for detection of transmurality aredetected, a predetermined number of plateaus in impedance have beendetected or until an overall maximum time for the ablation is achieved.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a type of electrosurgical hemostat that may beused in conjunction with the present invention.

FIGS. 2 a and 2 b illustrate alternative electrode configurations for ahemostat generally according to FIG. 1.

FIG. 3 illustrates the fall and plateau of impedance measured acrosstissue ablated using a bi-polar, saline irrigated electro surgicalhemostat.

FIG. 4 is a functional block diagram of an RF generator appropriate foruse in practicing the present invention, particularly adapted for use inconjunction with an ablation system employing multiple, individuallyactivatable electrodes or multiple electrode pairs.

FIG. 5 a is a functional flow chart illustrating a first mode ofoperation of the device illustrated in FIG. 4 in practicing the presentinvention.

FIG. 5 b illustrates an alternative mode of operation of a device as inFIG. 4 in practicing the present invention.

FIG. 6 illustrates an additional alternative mode of operation of adevice as in FIG. 4 in practicing the present invention.

FIG. 7 illustrates a first mode of operation of a device as in FIG. 4 toactivate and deactivate of individual electrodes or electrode pairs.

FIG. 8 illustrates a second mode of operation of a device as in FIG. 4to activate and deactivate individual electrodes or electrode pairs.

FIGS. 9–12 are graphs illustrating modes of operation for a deviceaccording to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is a plan view of a bipolar, saline irrigated electrosurgicalhemostat of a type that may be employed in conjunction with the presentinvention. The hemostat is provided with elongated handles 11 and 12 anda lock mechanism 14, similar to a conventional surgical hemostat. Thehandles are connected to one another by pivot or hinge 16, and continuedistally in the form of elongated jaws 18 and 19. Jaws 18 and 19 carryan elongated electrode or series of electrodes 24, 25, respectively, towhich ablation energy, e.g. RF energy is applied by means of conductors21 and 22. The electrodes are adapted to be irrigated by a salinesolution or other conductive fluid along their length, provided viainlet tubes 20 and 23. In operation, tissue to be ablated is compressedbetween the jaws, and RF energy is applied between the electrode orelectrode sets 24 and 25, as generally described in U.S. Pat. No.6,096,037 issued to Mulier et al incorporated herein by reference in itsentirety.

FIG. 2 a shows a first embodiment of an electrode arrangement for ahemostat generally as illustrated in FIG. 1. Illustrated componentscorrespond to identically numbered components in FIG. 1. In thisembodiment, electrodes 24 and 25 take the form of elongated coilelectrodes 30 and 32, mounted around porous tubes 34 and 36, throughwhich saline or other conductive fluid is delivered. The arrangement ofthe electrodes may also be reversed, for example placing coils 30 and 32within elongated porous tubes 34 and 36, to accomplish a similar result.Alternatively, any other arrangement for providing an elongatedelectrode and delivery of saline solution along the length thereof maybe substituted. The particular configuration of the electrode is notcritical to the present invention. For example, irrigated electrodescorresponding to those described in U.S. Pat. No. 6,096,037 issued toMulier, et al., U.S. Pat. No. 5,876,398 issued to Mulier, et al., U.S.Pat. No. 6,017,378 issued to Brucker, et al or U.S. Pat. No. 5,913,856issued to Chia, et al., all incorporated herein by reference in theirentireties may also be substituted. It should also be noted that whilethe electrode system as illustrated in FIG. 2 a is a bipolar system, theinvention may also be employed in conjunction with unipolar electrodesand/or in the form of a probe or a catheter. In some embodiments,irrigation of the electrodes may be omitted.

FIG. 2 b illustrates an alternative embodiment of an electrode systemfor a hemostat generally as illustrated in FIG. 1. In this case, ratherthan a single pair of electrodes, multiple electrode pairs are provided.The electrode pairs comprise coil electrodes 40 and 42, 44 and 46, 48and 50, 52 and 54, and 56 and 58. However, other pairings of electrodesmight also be substituted, for example, pairing electrodes 40 and 44,electrodes 48 and 52 or the like. In this embodiment, the electrodepairs are mounted around porous plastic tubes 60 and 62 through whichsaline or other electrically conductive fluid is delivered. As in thecase with the embodiment of FIG. 2 a, the arrangement of theseelectrodes may readily be reversed, placing the electrodes within thelumen of plastic tube 60 or 62 and any other arrangement providingmultiple, irrigated electrodes may also be substituted. As in the caseof the embodiment of FIG. 2 a, unipolar electrodes might be substitutedfor the multiple bipolar pairs as illustrated and/or the invention maybe practiced in conjunction with a multi-electrode probe or catheter.While the particular arrangement of electrodes is not believed criticalto practicing the present invention, it is believed that the inventionmay be most beneficially practiced in conjunction with a set of linearlyarranged bipolar electrode pairs as illustrated in FIG. 2 b.

In use, the hemostat is arranged so that the tissue to be ablated islocated between the jaws 18 and 19, and pressure is applied in order tocompress the tissue slightly between the jaws to ensure good electricalcontact. All electrode pairs may be activated individually and may beindividually deactivated when the lesions between the individualelectrode pairs are completely transmural. Alternatively, electrodepairs could be activated sequentially, with one pair deactivated upon adetection of a complete lesion between the electrode pair, followed byactivation of the next sequential electrode pair. Corresponding use ofthe invention in conjunction with a series of unipolar electrodes, forexample corresponding to electrodes along one of the two jaws inconjunction with a remote ground plate or a similar series ofindividually activatable electrodes on a catheter or probe inconjunction with a ground plate is also possible.

FIG. 3 is a graph illustrating measured impedance versus time acrosstissue located between the electrodes of an irrigated bipolar hemostatas illustrated in FIG. 1. FIG. 3 illustrates the drop in impedancefollowed by an impedance plateau, ultimately followed by an impedancerise. The impedance plateau is the primary indicator of transmuralityemployed by the present invention. Following the impedance plateau, astissue is desiccated or as steam or microbubbles forms in the tissue, animpedance rise will generally occur. In some embodiments of theinvention, the detection of this rise in impedance is employed as analternative or mechanism for assessing transmurality and/or as a safetymechanism in order to assure shut off of the ablation electrodes beforeexcessive physical damage to the tissue results.

FIG. 4 is a functional block diagram illustrating one embodiment of anRF generator system for use in conjunction with the present invention.In this embodiment, separately controllable RF outputs are provided forindividual ablation electrodes or electrode pairs on an associated RFablation device, for example as in FIG. 2B. The RF generator could ofcourse also be used with ablation devices having only a single electrodeor electrode pair as in FIG. 2A. With the exception of the electrogramamplitude measurement circuits discussed below, the generatorcorresponds generally to that described in conjunction with FIG. 14 ofthe '961 patent issued to Maguire, et al., cited above. The RF generatordisclosed in the '961 patent provides feedback control of RF power basedupon either measured power (constant power) or temperature. The presentinvention is somewhat easier to implement in conjunction with theconstant power mode, but may also be adapted to a temperature-regulatedmode or to other feedback power regulation mechanism.

Display 804 and controls 802 are connected to a digital microprocessor800, which permits interface between the user and the remainder of theelectrical components of the system. Microprocessor 800 operates undercontrol of stored programming defining its operation includingprogramming controlling its operation according to the presentinvention, as discussed in more detail below. Microprocessor 800provides control outputs to and receives input signals from theremaining circuitry via address/data bus 806. In particular, themicroprocessor 800 provides for monitoring of power, current, voltage,impedance and temperature. As necessary, the microprocessor will providethis information to the display 804. Additionally, the microprocessor800 permits the user to select the control mode (either temperature orpower) and to input the power set point, temperature set point, and atimer set point to the system. The primary source of power for theradio-frequency generator may be a 12 V battery rated at 7.2ampere-hours. Alternatively, the device may be AC powered. A back-upbattery (not shown) such as a lithium cell may also be provided toprovide sufficient power to the microprocessor 260 to maintain desiredmemory functions when the main power is shut off.

The power supply system as illustrated includes a desired number “M” ofindividually controllable RF power supplies and receives temperatureinputs from a desired number “N” of temperature sensing devices in theablation device, illustrated schematically at 838 and receivestemperature inputs from a desired number “M” of impedance monitoringcircuits. Each RF power supply includes a transformer (822, 824, 826), apower control circuit (810, 812, 814) and a power measurement circuit(816, 818, 820). A crystal-locked radio-frequency oscillator 264generates the switching pulses, which drive both the power transformers(822, 824, 826) and the power controllers (810, 812, 814). Powercontrollers (810, 812, 814) may be analog controllers which operate bypulse-width modulation by comparing a power set point signal frommicroprocessor 800 with an actual power signal generated by a powermeasurement circuit (816, 818, 820), which may, for example, include atorroidal transformer coupled to the power output from the associatedtransformer (822, 824, 826). The power measurement circuits (816, 818,820) multiply the output current and voltage and provide the resultingactual power signal to both the power controllers (810, 812, 814) andthe microprocessor 800.

The RF power output of the transformers (822, 824, 826) is provided tointer face board 808, and thereby is provided to the ablation electrodeor electrodes on the ablation device 838. Separate analog comparatorcircuits (not illustrated) may also be provided for monitoring theoutput of the power measurement circuits (816, 818, 820), in order toshut-off current to the output transformers (822, 824, 826) if the powerexceeds a limit, typically 55 watts. Power transformers (822, 824, 826)may include center taps, which receive the outputs of the powercontrollers (810, 812, 814). Secondary windings of the transformers(822, 824, 826) may provide for continuous monitoring of the appliedvoltage in order to permit the power calculations by power measurementcircuits (816, 818, 820).

The illustrated power RF generator system employs software controlledtemperature processing, accomplished by micro processor 800, whichreceives the “N” temperature input signals from temperature measurementcircuits (828, 830, 832), each of which are coupled to a correspondingtemperature sensor in ablation device 838 by means of an electricalconnector, illustrated schematically at 836 and interface circuit 834.If programmed to operate in the temperature controlled mode, processor800 receives the “N” temperature signals and, based upon the indicatedtemperatures, defines power set points for each of the power controlcircuits (810, 812, 814), which in the manner described above controlthe power levels applied to electrodes on the catheter through interface834. Processor 800 may also selectively enable or disable any of the “M”provided RF power sup plies, in response to external control signalsfrom controls 802 or in response to detected anomalous temperatureconditions.

In addition to the circuitry as described above and disclosed in anddisclosed in the Maguire, et al. '961 patent, the apparatus of FIG. 4includes multiple impedance monitoring circuits ZM1, ZM2. . . ZMM (842,844 and 846 respectively), which may operate as described in U.S. Pat.No. 5,733,281, issued to Nardella, or U.S. Pat. No. 5,863,990, issued toLi, also both incorporated herein by reference in their entireties tomeasure an impedance between electrodes on a RF ablation device.Impedance may be measured between the ablation electrodes or betweenelectrodes located adjacent the ablation electrodes, as described inU.S. Pat. No. 5,558,671, incorporated by reference above. Individualimpedance measurements made by measurement circuits 842, 844 and 846 areprovided to the address/data bus 806 and thence to microprocessor 800for analysis to determine whether the impedance over time, indicatesthat the lesion associated with the measured impedance is completelytransmural. As discussed in more detail below, a determination oftransmurality is made in response to a detection of a series ofimpedance measurements that are relatively constant, over a desiredperiod of time or over a defined number of successive impedancemeasurements. In some embodiments, an abrupt rise in impedance may alsobe employed to terminate delivery of ablation energy.

As an alternative to dedicated impedance monitoring circuits, themicroprocessor may employ voltage and current measurements of impedancemeasurement signals generated by the power transformers (822, 824, 826)to derive impedance and may use such derived impedance values inconjunction with the present invention. For example, measurement ofimpedance in this fashion is disclosed in U.S. Pat. No. 5,540,681,issued to Struhl, et al, cited above or U.S. Pat. No. 5, 573,533, issuedto Struhl, also incorporated herein by reference in its entirety.

In cases in which an alternative ablation energy generation apparatus isemployed, particularly those in which a rise in tissue temperature isinduced, e.g. laser, microwave or thermal ablation, the RF generationcircuitry of FIG. 4 would be replaced with a corresponding alternativeablation energy generation apparatus. The measurement of tissueimpedance and its use according to the present invention, however, maystill be useful in conjunction with these alternative ablation energygeneration systems.

FIG. 5A is a functional flow chart illustrating the operation of adevice as in FIG. 4, according to the present invention. The flow chartof FIG. 5A illustrates operation of the device of FIG. 4 to controlprovision of RF energy to an individual electrode or electrode pair. Inthe event that multiple electrodes or electrode pairs are employed, thecontrol methodology of FIG. 5A would be applied to each electrode orelectrode pair individually, as discussed in more detail below inconjunction with FIGS. 7 and 8.

The flow chart of FIG. 5A illustrates a method of assessingtransmurality and terminating delivery of ablation energy to anelectrode or an electrode pair responsive to detection of a plateau inimpedance in conjunction with a detected drop in impedance. Followingthe detection of a plateau in conjunction with the required impedancedrop, the device waits a defined time period and then terminates theapplication of ablation energy to the associated electrode pair.Measurement of impedance in tissue associated with the electrode pairmay be made using the ablation electrodes themselves or electrodeslocated in proximity to the ablation electrodes, for example asdescribed in the Yates '671 patent, incorporated by reference above.

After initialization at 200, the microprocessor 800 (FIG. 4) initiatesdelivery of ablation energy at 201 and causes the impedance measurementcircuitry associated with the electrode or electrode pair beingevaluated or derives impedance based on applied voltage and current asdiscussed above to acquire a base line or initial impedance Z_(i), whichmay be, for example the maximum impedance during the first three secondsof ablation. At 202 and 204 counts “n” “m” are reset to zero. Themicroprocessor thereafter acquires a current impedance value Z_(n) at206. The value of “n” is incremented at 208 and compared with apredefined value “a” at 210 to determine whether a sufficient number ofimpedances have been measured in order to calculate the rate of changeof impedance (dZ/dt). For example, dZ/dt may be calculated by taking themeasured impedance Z_(n) and comparing it to the preceding measuredimpedance Z_(n-1), in which case n would have to be greater or equal to2 in order for dZ/dt to be calculated. Alternatively, dZ/dt may becalculated by taking the measured impedance Z_(n) and comparing it tothe previously measured impedance Z_(n-2), in which case n would have tobe greater or equal to 3 in order for dZ/dt to be calculated. If“n” isless than “a” at 210, the microprocessor waits an impedance samplinginterval Δt₁ which may be, for example, 0.2 seconds, and then triggersan impedance measurement again at 206. This process continues untilthere are a sufficient number of collected impedance measurements tocalculate dZ/dt at 212.

At 212, the microprocessor 800 employs the stored impedance measurementsto calculate dZ/dt, which may, for example, be calculated as equal to(1/(2Δt₁))(Z_(n)-Z_(n-2)) The absolute value of dZ/dt, i.e., |dZ/dt|_(n)is employed to assess whether or not an impedance plateau has beenreached at 214. The microprocessor checks at 214 to determine whether|dZ/dt|_(n) is less than a defined constant b, indicative of a minimalrate of change of impedance. In the case of an elongated, fluidirrigated ablation electrode similar to that illustrated in FIG. 2A, forexample using an electrode of approximately 5 centimeters in lengthoperated in a constant power mode with a power of less than 27 watts, anappropriate value of “b” might be 1.3. For other electrodeconfigurations and other power levels, the value of “b” may have to beadjusted. Other power control modes, e.g. temperature controlled wouldsimilarly require adjustment of this parameter. The value of “b” andother parameters employed to determine transmurality using the presentinvention can be determined empirically in the laboratory by applyingthe specific electrode set and RF generation system in question to testspecimens, reading impedances at defined sample intervals and using theresults to optimize the various parameters.

In the event that |dZ/dt|_(n) is sufficiently small in value at 214, thecount “m” is incremented at 216 and m is compared to a third constant“c” which sets forth the defined number of low value |dZ/dt|_(n)measurements required to detect an impedance plateau. For example, in asystem as described herein, “c” may be 6–12. Alternatively, rather thanrequiring an entire series of measured |dZ/dt|_(n) values to be lessthan “b”, a requirement that a defined proportion of the |dZ/dt|_(n)values must be less than “b” may be substituted, e.g. 8 of 12, or thelike.

If the number of low values of |dZ/dt|_(n) is less than “c” at 218, themicroprocessor waits the impedance sampling interval Δt₁ at 220 andcontinues to acquire successive impedance measurements until sufficientnumber of sequential low values of |dZ/dt|_(n) have occurred at 218. Atthat point, the microprocessor then compares the current impedance valueZ_(n) with the initial impedance value Z_(i) to determine whether asufficient impedance drop has occurred. If not, the microprocessor waitsfor the next impedance sampling interval at 220 and continues to collectimpedance measurements and make calculations of |dZ/dt|_(n) until suchtime as an impedance plateau is recognized at 218 and a sufficientimpedance drop is recognized at 220. When both of these criteria havebeen met at 220, the microprocessor than waits for an additional timeinterval Δ_(t2) to assure completeness of the lesion at 222 andthereafter terminates the provision of ablation energy to the specificelectrode pair being regulated at 224 and the ablation process withregard to that electrode or electrode pair is terminated at 226.

FIG. 5B illustrates an additional set of operations for implementing atransmurality measurement method generally as in FIG. 5A. The operationsof FIG. 5B may either be a substituted for step 222 of FIG. 5A oralternatively may be performed before or after step 222. In theadditional operations illustrated in FIG. 5B, the microprocessorincreases the power to the electrodes under consideration slightly at228 and sets a timer at 230. The microprocessor then causes theimpedance measurement apparatus associated with the electrodes underconsideration to measure current impedance at 234 and calculate|dZ/dt|_(n) at 236, in the same fashion as discussed above. In the eventthat the value of |dZ/dt|_(n) is greater then a defined constant “e” at240, the microprocessor returns to 204 and resets the value of “m” tozero, essentially reinitializing the search for an impedance plateau.The value of “e” may be equal to “b” or may be different. If the valueof |dZ/dt|_(n) is sufficiently small at 240, the microprocessor checksat 242 to determine whether the timer has expired. If not, themicroprocessor waits the impedance sampling interval Δ_(t1) at 238 andcontinues to collect impedance values and calculate |dZ/dt|_(n) valuesuntil expiration of the timer at 242, at which point it eitherterminates ablation at 224 or initiates the waiting period Δ_(t1) at222.

FIG. 6 illustrates a second basic approach to assessment oftransmurality and control of delivery of ablation energy to an electrodepair. In the same fashion as for FIGS. 5 a and 5 b, the proceduredefined by the flow chart of FIG. 6 it should be understood to beemployed in conjunction with an impedance measurement circuit with asingle electrode pair, which procedure would be repeated for otherelectrodes or electrode pairs, if present. After initiation at 300, thevalue of “n” is set to Zero at 302 and a timer is initiated at 304, usedto determine that a sufficient amount of time has passed prior totermination of ablation. For example, in the context of a bipolarirrigated hemostat similar to FIGS. 1 and 2 a as described above, havingelectrode lengths of 2 to 5 centimeters and receiving RF energy at alevel of 27 watts or less, ten seconds may be an appropriate timeinterval for the timer initiated at 304.

The microprocessor than measures the current impedance Z_(n) at 310increments the value of“n” at 310 and checks at 314 to determine whetheran adequate number of impedance measurements have been accumulated tomake a calculation of dZ/dt at 314, in the same fashion as discussedabove in conjunction with FIGS. 5 a and 5 b. If an inadequate number ofsamples have been collected, the microprocessor waits the impedancesampling interval Δ_(t) at 308 and continues to collect impedancemeasurements until an adequate number “a” of measurement have beencollected. In the specific example presented, “a” may be set equal to 5and Δ_(t) may be 0.2 seconds. After an adequate number of impedancemeasurements have been collected at 314, the microprocessor calculatesthe value of dZ/dt_(n) and |dZ/dt|_(n) at 316. In conjunction with thespecific mechanism of plateau detection illustrated in FIG. 6, filteredor average impedance values Z_(a) may be employed to calculate dZ/dt and|dZ/dt|_(n).

For example, at 316, the microprocessor may calculate the value of dZ/dtaccording to the following method. The microprocessor may employ a 5point moving average filter to produce an average impedance value Z_(a),which is equal to (Z_(n)+Z_(n-1)+Z_(n-2)+Z_(n-3)+Z_(n-4))/5. The valueof dZ/dt_(n) and |dZ/dt|_(n) may be calculated in the same fashion as inconjunction with the flow charts of FIGS. 5A and 5B discussed above,substituting the averaged impedance values Z_(a) for the individualimpedance values Z_(n) as employed in the previous flow charts. In thiscase, dZ/dt_(n) would be (1/(2Δ_(t))) (Z_(n)-Z_(n-2)) and |dZ/dt|_(n)would be the absolute value of dZ/dt.

At 318, microprocessor 308 may attempt to determine whether an impedanceplateau has been reached employing the following method. Themicroprocessor reviews the preceding 15 measurements of dZ/dt_(n), and|dZ/dt|_(n) and applies three criteria to those values, all three ofwhich must be met in order for an impedance plateau to be detected. Fora fluid irrigated hemostat as described, the rules may be as follows:for n=1 to 15; |dZ/dt|_(n) must be less than or equal to 1 for all 15;and for n=1 to 15 the value of dZ/dt_(n) must be less than or equal to0.75, for thirteen of the 15; and for n=1 to 15, |dZ/dt|_(n) must beless than or equal to 0.5, for 10 of the 15. If all of these criteriaare met at 318, the microprocessor checks at 319 to determine whether anadequate period of time has elapsed since ablation was initiated, ifnot, the microprocessor waits for the impedance sampling interval Δ_(t)at 312 and continues to measure impedances and calculate values of dZ/dtaccording to the above described method until both a plateau is presentand the defined time period “b” has elapsed at 319. After the requiredtime period at “b” at 319 has elapsed, delivery of ablation energy tothe associated electrode or electrode pair is terminated at 322 and theablation process ceases at 324 as to that electrode pair.

In this embodiment, in the event that an impedance plateau fails tomanifest itself, the microprocessor may nonetheless safely terminateprovision of ablation energy to the electrode pair under considerationin response to a detected rapid rise in impedance, which normallyfollows the impedance plateau. In the event that a plateau is notdetected at 318, the microprocessor checks the preceding stored valuesof dZ/dt_(n) to look for a rapid rise in impedance. For example, a rapidrise in impedance may be detected using the following rule: for n=1 to10, dZ/dt_(n) must be greater than or equal to 1.0 for all 10. If thisrapid rise criteria is met at 320, the processor checks to see whetherthe required minimal time period has elapsed at 319, and if so,terminates ablation at 322 as discussed above. If the minimal timeinterval “b” has not elapsed, the microprocessor continues to acquiremeasurements of impedance and continues to calculate values of dZ/dt and|dZ/dt|_(n) until either an impedance plateau is detected at 318 or arapid rise in impedance is detected at 320 and the minimum time intervalhas expired at 319.

FIG. 7 is a function flow chart illustrating the over-all operation ofthe device in conjunction with a multi electrode or multi electrode pairablation apparatus. In the flow chart of FIG. 7, all the electrodes areactivated simultaneously and individual electrodes or electrode pairsare deactivated in response to impedance measurements associated withthe electrode pair indicating that the lesion formed between thatelectrode pair is completely transmural. In this circumstance, theablation system works as follows.

After initialization at 406, all electrodes 1-x are activated at 402,meaning that ablation energy is provided to all electrodes and electrodepairs. The microprocessor then checks the value of dZ/dt and/or |dZ/dt|at the first of the electrode pairs at 404, using any of the mechanismsdiscussed above in conjunction with FIGS. 5 a, 5 b and 6. At 408, themicroprocessor checks using any of the mechanisms described above todetermine whether an impedance plateau has been reached or, in the eventthat additional criteria for shut off of ablation energy are provided,to see whether any of these additional criteria are reached. If so, theelectrode being examined is deactivated at 410 by ceasing the deliveryof ablation energy to the electrode or electrode pair. If not, themicroprocessor checks the value of dZ/dt and/or |dZ/dt| for the nextelectrode at 406. This process continues until all electrodes aredeactivated at 412, after which the procedure is deemed complete at 414and the ablation process is terminated at 416.

FIG. 8 illustrates a functional flow chart of overall operation of adevice in which a multi-electrode or multi-electrode pair ablationapparatus is employed, as in FIG. 7. In this embodiment, however,electrodes or electrode pairs are activated initially and sequentially.After initialization at 500, the microprocessor activates delivery ofablation energy to the first electrode at 502, checks dZ/dt and/or|dZ/dt| at 504 and, in the same manner as described for FIG. 7 above,checks to determine whether the impedance plateau criteria and/or othercriteria as described above have been met. If so, the electrode isdeactivated at 510. If not, application of ablation energy continuesuntil the plateau criterion or other criteria are met as describedabove. After deactivation of an electrode at 510, the microprocessorchecks to determine whether all electrodes have been activated anddeactivated at 512, if not, the microprocessor then activates the nextelectrode at 506 and initiates delivery of ablation energy to thatelectrode. This process continues until the last electrode has beendeactivated at 512, following which the microprocessor determines thatthe ablation process is complete at 514 and the ablation process isstopped at 516.

The overall operational methodology of FIG. 7 is believed to bedesirable in that it allows for a more rapid completion of an ablationprocedure. However, the overall operational method is described in FIG.8 has the advantage that it may allow the use of a somewhat simplifiedgenerator because that multiple, separate impedance measurementcircuits, power control circuits, and the like need not be provided foreach electrode or electrode pair. A simple switching mechanism may beused in conjunction with only a single RF generator and impedancemeasurement circuit to successively apply energy to each electrode andto monitor impedance according to the invention.

FIGS. 9–12 show yet another aspect of the invention in which RF powerdelivery can also be controlled in order to assist in the assessment oflesion transmurality. The ablation commences at a first power level andis then increased to a second power level as certain conditions aresatisfied. The power level can also be increased from the second powerlevel to a third power level and in the same stepwise manner, increasingthe power level from an N power level to an n+1 power level until a setof conditions are met that indicates that transmurality has beenachieved and/or that the power should be turned off. For example, aninitial power level P₀ can be selected in the range of about 10 to 25watts. The power level can then be rapidly increased to a second powerlevel P₁ in an increment in the range of about 3 to 10 watts at a rateof at least about 0.5 watts/second. Subsequent power levels P₂, P₃, etc.can be similarly achieved. A maximum permitted power in the range ofabout 25–50 watts can also be selected to ensure that the power level isnot raised beyond safe limits. Typical power levels could be an initialpower level P₀ of about 25 watts and a second power level P₁ of about 30watts. Power levels P2, P3, etc. could be increased in similarincrements until a maximum power level of about 40 watts was achieved.

In each of the FIGS. 9–12, an initial selected power level P₀ is eithermaintained or increased to a second power level in response to changesin the detected impedance occurring during the ablation. In each case,the initial detected impedance Z₀ drops initially as ablation proceeds.However, each of FIGS. 9–12 shows exemplary alternative responses of asystem according to the invention as differing impedance conditions aredetected. In FIG. 9, the power level remains the same during the entireablation procedure because a detected rapid rise in impedancedZ/dt_(rise) is detected without first detecting a plateau. Onecondition indicating that transmurality has been achieved is a rapidrise in impedance such as that shown in FIG. 9. Upon detecting a rapidrise in impedance, the power is turned off and the ablation for thelesion is completed. Conditions for an increase in power level caninclude one or more of: the detection of a plateau in impedance or aslow rise in impedance or the achievement of a maximum permitted timefor that power level. Conditions indicating that transmurality has beenachieved can include one of: the lack of change in detected impedance inresponse to the change in power level or the detection of a rapid risein impedance. FIG. 10 shows the detection of a plateau in the impedancecurve at dZ/dt₁, which triggers a rapid increase in power level from P₀to P₁. The increase in power level causes a drop in impedance andtherefore the ablation is continued at the second power level P₁ untilthe detected impedance indicates a rapid rise dZ/dt_(rise). Upondetection of the rapid impedance rise, the power is turned off and theablation for the lesion is completed. In the event that neither aplateau or a rapid rise is detected, ablation at the power level P₀ maybe continued for a maximum pre-selected period of time followed by anincrease in power level to power level P₁. For example, a time in therange of about 3 to 20 seconds, or more preferably about 8 seconds couldbe selected as the maximum duration for ablation at a particular powerlevel. FIG. 11 shows the detection of a plateau in impedance at dZ/dt₁which triggers an increase in power level from P₀ to P₁. Because theimpedance drops in response to the increased power level, ablationcontinues at the second power level P₁ until a second plateau inimpedance is detected at dZ/dt₂. The detection of the second impedanceplateau triggers a second increase in power level, from P₁ to P₂.Because the impedance drops in response to the increase in power level,ablation is continued at the third power level P₂ until a rapid rise inimpedance is detected at dZ/dt_(rise). Upon detection of the rapidimpedance rise, the power is turned off and the ablation for the lesionis completed. FIG. 12 shows the detection of a plateau in impedance atdZ/dt₁, which triggers an increase in power level from P₀ to P₁. Becausethe impedance drops in response to the increased power level, ablationcontinues at the second power level P₁ until a second plateau isdetected at dZ/dt₂. The detection of the second plateau triggers asecond increase in the power level from P₁ to P₂. Because the impedancedoes not drop in response to the increase in power level from P₁ to P₂,the continued plateau is verified by impedance measurement at dZ/dt₃ andthe ablation is immediately terminated. Each of FIGS. 9–12 illustratessuccessful termination of ablation by detecting impedance that ischaracteristic of achievement of transmurality. If the detection ofimpedance does not indicate the achievement of transmurality, theablation can still be terminated if the total time for the ablationexceeds a predetermined limit. For example, a total limit on ablation toform the lesion could take about 30 to 60 seconds, and preferably about40 seconds. Alternatively, ablation could also be stopped upon reachinga maximum power level or after the completion of a predetermined numberof power level increases.

1. A method of ablation, comprising: applying ablation energy to a firsttissue site; monitoring impedance of the first tissue site; andresponsive to occurrence of an impedance plateau at the first tissuesite, increasing application of ablating energy to the first tissuesite.
 2. A method as in claim 1 wherein the applying of ablation energyto the first tissue site comprises applying RF energy using a first RFelectrode.
 3. A method as in claim 2 wherein the monitoring of impedanceof the first tissue site comprises monitoring impedance using the firstRF electrode.
 4. A method as in claim 2 wherein monitoring of impedanceof the first tissue site comprises monitoring voltage and currentmeasurements to derive impedance.
 5. A method as in claim 1 whereinmonitoring of impedance of the first tissue site comprises monitoringimpedance using dedicated monitoring electrodes.
 6. A method as in claim1 wherein the applying of RF energy to the first tissue site comprisesapplying RF energy using an irrigated first RF electrode.
 7. A method asin any of claims 1–6, wherein the increasing of application of ablatingenergy to the first tissue site comprises increasing application ofablation energy responsive to a series of monitored impedances that havean acceptable degree of change.
 8. A method as in any of claims 1–6,wherein the increasing of application of ablating energy to the firsttissue site comprises increasing application of ablation energyresponsive to a series of monitored impedances that have an acceptablerate of change.
 9. A method as in claim 1, further comprising: applyingablation energy to a second tissue site; monitoring impedance of thesecond tissue site; and responsive to occurrence of an impedance plateauat the second tissue site, increasing application of ablating energy tothe second tissue site.
 10. A method as in claim 9 wherein the applyingof ablation energy to the second tissue site comprises applying RFenergy using a second RF electrode.
 11. A method as in claim 10 whereinthe monitoring of impedance of the second tissue site comprisesmonitoring impedance using the second RF electrode.
 12. A method as inclaim 10 wherein monitoring of impedance of the second tissue sitecomprises monitoring voltage and current measurements to deriveimpedance.
 13. A method as in claim 9 wherein monitoring of impedance ofthe second tissue site comprises monitoring impedance using dedicatedmonitoring electrodes.
 14. A method as in claim 9 wherein the applyingof RF energy to the second tissue site comprises applying RF energyusing an irrigated second RF electrode.
 15. A method as in any of claims9–14, wherein the increasing of application of ablating energy to thesecond tissue site comprises increasing application of ablation energyresponsive to a series of monitored impedances that have an acceptabledegree of change.
 16. A method as in any of claims 9–14, wherein theincreasing of application of ablating energy to the second tissue sitecomprises increasing application of ablation energy responsive to aseries of monitored impedances that have an acceptable rate of change.17. A method as in any of claims 9–14, wherein the applying of ablationenergy to the first and second ablating means is initiatedsimultaneously.
 18. A method as in any of claims 9–14, wherein theapplying of ablation energy to the second ablating means is initiatedfollowing termination of application of ablation energy to the firstablating means.
 19. A method of ablation, comprising: applying ablationenergy to a first tissue site; monitoring impedance of the first tissuesite; responsive to occurrence of an impedance plateau at the firsttissue site, increasing application of ablating energy to the firsttissue site; and responsive to occurrence of a rise in impedance at thefirst tissue site, modifying application of ablating energy to the firsttissue site.
 20. A method as in claim 19 wherein the applying ofablation energy to the first tissue site comprises applying RF energyusing a first RF electrode.
 21. A method as in claim 20 wherein themonitoring of impedance of the first tissue site comprises monitoringimpedance using the first RF electrode.
 22. A method as in claim 20wherein monitoring of impedance of the first tissue site comprisesmonitoring voltage and current measurements to derive impedance.
 23. Amethod as in claim 20 wherein monitoring of impedance of the firsttissue site comprises monitoring impedance using dedicated monitoringelectrodes.
 24. A method as in claim 20 wherein the applying of RFenergy to the first tissue site comprises applying RF energy using anirrigated first RF electrode.
 25. A method as in claim 19 wherein themodifying of application of ablating energy comprises termination ofablating energy.
 26. A method as in any of claims 19–25, wherein theincreasing of application of ablating energy to the first tissue sitecomprises increasing application of ablation energy responsive to aseries of monitored impedances that have an acceptable degree of change.27. A method as in any of claims 19–25, wherein the modifying ofapplication of ablating energy to the first tissue site comprisesmodifying application of ablation energy responsive to a series ofmonitored impedances that have an acceptable degree of change.
 28. Amethod as in any of claims 19–25, wherein the increasing of applicationof ablating energy to the first tissue site comprises increasingapplication of ablation energy responsive to a series of monitoredimpedances that have an acceptable rate of change.
 29. A method as inany of claims 19–25, wherein the modifying of application of ablatingenergy to the first tissue site comprises modifying application ofablation energy responsive to a series of monitored impedances that havean acceptable rate of change.
 30. A method as in claim 19, furthercomprising: applying ablation energy to a second tissue site; monitoringimpedance of the second tissue site; responsive to occurrence of animpedance plateau at the second tissue site, increasing application ofablating energy to the second tissue site; and responsive to occurrenceof an impedance rise at the second tissue site, modifying application ofablating energy to the second tissue site.
 31. A method as in claim 30wherein the applying of ablation energy to the second tissue sitecomprises applying RF energy using a second RF electrode.
 32. A methodas in claim 31 wherein the monitoring of impedance of the second tissuesite comprises monitoring impedance using the second RF electrode.
 33. Amethod as in claim 31 wherein monitoring of impedance of the secondtissue site comprises monitoring voltage and current measurements toderive impedance.
 34. A method as in claim 30 wherein monitoring ofimpedance of the second tissue site comprises monitoring impedance usingdedicated monitoring electrodes.
 35. A method as in claim 30 wherein themodifying of application of ablating energy comprises termination ofablating energy.
 36. A method as in claim 31 wherein the applying of RFenergy to the second tissue site comprises applying RF energy using anirrigated second RF electrode.
 37. A method as in any of claims 30–36,wherein the increasing of application of ablating energy to the secondtissue site comprises increasing application of ablation energyresponsive to a series of monitored impedances that have an acceptabledegree of change.
 38. A method as in any of claims 30–36, wherein themodifying of application of ablating energy to the second tissue sitecomprises modifying application of ablation energy responsive to aseries of monitored impedances that have an acceptable degree of change.39. A method as in any of claims 30–36, wherein the increasing ofapplication of ablating energy to the second tissue site comprisesincreasing application of ablation energy responsive to a series ofmonitored impedances that have an acceptable rate of change.
 40. Amethod as in any of claims 30–36, wherein the modifying of applicationof ablating energy to the second tissue site comprises modifyingapplication of ablation energy responsive to a series of monitoredimpedances that have an acceptable rate of change.
 41. A method as inany of claims 30–36, wherein the applying of ablation energy to thefirst and second ablating means is initiated simultaneously.
 42. Amethod as in any of claims 30–36, wherein the applying of ablationenergy to the second ablating means is initiated following terminationof application of ablation energy to the first ablating means.